Ibrance

Product NDC
63539-187
11-digit product format
635390187
Labeler code
63539
Product ID
63539-187_fa0d4a01-f6f9-4e10-ad58-fdfd23a8ead2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
palbociclib
Dosage form
CAPSULE
Route
ORAL
Labeler
U.S. Pharmaceuticals
Application
NDA207103
Marketing category
NDA
Marketing start
2017-05-08
Substance
PALBOCICLIB
Active strength
75 mg/1
Pharmacologic classes
Cytochrome P450 3A Inhibitors [MoA], Kinase Inhibitor [EPC], Kinase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c1f85e95-ece0-4b26-a786-e9ff64eb69dcProduct name120200415
5a4db755-de93-485c-89bf-cac499b46d8cProduct name220160328

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63539-187-11Ibrance21 in 1 BOTTLECAPSULE2111

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PALBOCICLIBACTIVE INGREDIENTG9ZF61LE7GIBRANCE (PALBOCICLIB) CAPSULE [U.S. PHARMACEUTICALS]1
PALBOCICLIBACTIVE MOIETYG9ZF61LE7GIBRANCE (PALBOCICLIB) CAPSULE [U.S. PHARMACEUTICALS]1
AMMONIAINACTIVE INGREDIENT5138Q19F1XIBRANCE (PALBOCICLIB) CAPSULE [U.S. PHARMACEUTICALS]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UIBRANCE (PALBOCICLIB) CAPSULE [U.S. PHARMACEUTICALS]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OIBRANCE (PALBOCICLIB) CAPSULE [U.S. PHARMACEUTICALS]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675IBRANCE (PALBOCICLIB) CAPSULE [U.S. PHARMACEUTICALS]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTIBRANCE (PALBOCICLIB) CAPSULE [U.S. PHARMACEUTICALS]1
GELATININACTIVE INGREDIENT2G86QN327LIBRANCE (PALBOCICLIB) CAPSULE [U.S. PHARMACEUTICALS]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XIBRANCE (PALBOCICLIB) CAPSULE [U.S. PHARMACEUTICALS]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30IBRANCE (PALBOCICLIB) CAPSULE [U.S. PHARMACEUTICALS]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3IBRANCE (PALBOCICLIB) CAPSULE [U.S. PHARMACEUTICALS]1
SHELLACINACTIVE INGREDIENT46N107B71OIBRANCE (PALBOCICLIB) CAPSULE [U.S. PHARMACEUTICALS]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4IBRANCE (PALBOCICLIB) CAPSULE [U.S. PHARMACEUTICALS]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2IBRANCE (PALBOCICLIB) CAPSULE [U.S. PHARMACEUTICALS]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPIBRANCE (PALBOCICLIB) CAPSULE [U.S. PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63539-187IBRANCE (PALBOCICLIB) CAPSULE [U.S. PHARMACEUTICALS]9Current NDC, Legacy NDC, 1 package rows20250426_86718885-da44-4d3d-b3ca-06cbcedcffd8.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63539-187-116353901871121 CAPSULE in 1 BOTTLE (63539-187-11) 21 capsule2017-05-080000-00-00NoNoCurrent